Colorectal CancerNCT02613728
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
A study testing Accelerated Recovery Plan, Early Discharge and Telemedicine in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if RecoverMI care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner. RecoverMI includes the following parts: Preoperative Education Early oral intake Early mobilization Telemedicine Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Accelerated Recovery Plan, Early Discharge and Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2016to 8 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
- Patient is >/= 18 years and younger than 80 years.
- Elective minimally invasive operation.
- No planned ostomy creation at time of enrollment.
- Serum creatinine <1.5 measured within 30 days of surgery.
- Ability to speak, read, and understand English.
Who cannot join
- Strong, self-reported history of postoperative nausea and vomiting.
- History of congestive heart failure. Systolic heart failure defined as Ejection Fraction (EF) </= 40%), or diastolic heart failure defined as EF >40% PLUS systemic manifestation of heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if RecoverMI care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner.
RecoverMI includes the following parts:
- Preoperative Education
- Early oral intake
- Early mobilization
- Telemedicine
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is the same, better, or worse than the other group.
- If you are assigned to Group 1, you will receive standard enhanced care after your surgery.
- If you are assigned to Group 2, you will receive routine care after surgery, but you will also receive accelerated recovery, early discharge, and Telemedicine. Participants will be loaned an iPad to use for video-conferencing and text messaging in this study.
This is an investigational study. The study doctor can explain how RecoverMI is designed to work.
Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- Accelerated Recovery Plan, Early Discharge, Telemedicine, Standard Enhanced Care
- Keywords
- Colorectal cancer, Colorectal cancer surgery, Polyp(s), Accelerated Enhanced Recovery, RecoverMI, Fluid diary, Questionnaires, Surveys, RecoverMI device
- Medical subject headings
- Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Recovery PlanBehavioural
Early DischargeBehavioural
TelemedicineOther
Standard Enhanced CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | Active comparator | Standard enhanced care following minimally invasive colorectal cancer surgery Receives: Behavioral: Standard Enhanced Care |
| Intervention (RecoverMI) Arm | Experimental | Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery Receives: Behavioral: Accelerated Recovery Plan; Behavioral: Early Discharge; Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Hospital Length of Stay (LOS)
Measured: 30 days post transplant
Secondary outcomes (2)
Failure Rate (FR) in the RecoverMI Arm
Measured: 30 days
Patient Satisfaction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start13 May 2016
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Colon and Rectal Surgeons
- Responsible party
- Sponsor
- Investigators
- George Chang, MD, MS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613728
- Sponsor's protocol ID
- 2015-0583
- Other IDs
- NCI-2016-00742
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2015
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bednarski BK, Nickerson TP, You YN, Messick CA, Speer B, Gottumukkala V, Manandhar M, Weldon M, Dean EM, Qiao W, Wang X, Chang GJ. Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial). Br J Surg. 2019 Sep;106(10):1311-1318. doi: 10.1002/bjs.11223. Epub 2019 Jun 19.
PubMed 31216065Price BA, Bednarski BK, You YN, Manandhar M, Dean EM, Alawadi ZM, Bryce Speer B, Gottumukkala V, Weldon M, Massey RL, Wang X, Qiao W, Chang GJ. Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial. BMJ Open. 2017 Jul 20;7(7):e015960. doi: 10.1136/bmjopen-2017-015960.
PubMed 28729319
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
- ClinicalTrials.gov ID
- NCT02613728
- Acronym / sponsor ID
- 2015-0583
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Colorectal cancer surgery, Polyp(s), Accelerated Enhanced Recovery, RecoverMI, Fluid diary, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Society of Colon and Rectal Surgeons
- Study start
- 13 May 2016 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if RecoverMI care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner.
RecoverMI includes the following parts:
- Preoperative Education
- Early oral intake
- Early mobilization
- Telemedicine
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is the same, better, or worse than the other group.
- If you are assigned to Group 1, you will receive standard enhanced care after your surgery.
- If you are assigned to Group 2, you will receive routine care after surgery, but you will also receive accelerated recovery, early discharge, and Telemedicine. Participants will be loaned an iPad to use for video-conferencing and text messaging in this study.
This is an investigational study. The study doctor can explain how RecoverMI is designed to work.
Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | Active comparator | Behavioral: Standard Enhanced CareStandard enhanced care following minimally invasive colorectal cancer surgery |
| Intervention (RecoverMI) Arm | Experimental | Behavioral: Accelerated Recovery Plan, Behavioral: Early Discharge, Other: TelemedicineRoutine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
- Patient is >/= 18 years and younger than 80 years.
- Elective minimally invasive operation.
- No planned ostomy creation at time of enrollment.
- Serum creatinine <1.5 measured within 30 days of surgery.
Key exclusion criteria (2 listed)
- Strong, self-reported history of postoperative nausea and vomiting.
- History of congestive heart failure. Systolic heart failure defined as Ejection Fraction (EF) </= 40%), or diastolic heart failure defined as EF >40% PLUS systemic manifestation of heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Recovery Plan | Behavioural | Intervention (RecoverMI) Arm |
| Early Discharge | Behavioural | Intervention (RecoverMI) Arm |
| Telemedicine | Other | Intervention (RecoverMI) Arm |
| Standard Enhanced Care | Behavioural | Standard of Care Arm |
Primary outcome
Cumulative Hospital Length of Stay (LOS)
Time frame: 30 days post transplant
2 secondary outcomes
Failure Rate (FR) in the RecoverMI Arm
Time frame: 30 days
Patient Satisfaction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 31216065Bednarski BK, Nickerson TP, You YN, Messick CA, Speer B, Gottumukkala V, Manandhar M, Weldon M, Dean EM, Qiao W, Wang X, Chang GJ. Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial). Br J Surg. 2019 Sep;106(10):1311-1318. doi: 10.1002/bjs.11223. Epub 2019 Jun 19.
- Derived from this study: PubMed 28729319Price BA, Bednarski BK, You YN, Manandhar M, Dean EM, Alawadi ZM, Bryce Speer B, Gottumukkala V, Weldon M, Massey RL, Wang X, Qiao W, Chang GJ. Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial. BMJ Open. 2017 Jul 20;7(7):e015960. doi: 10.1136/bmjopen-2017-015960.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Chang, MD, MS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Recovery Plan, Early Discharge and Telemedicine in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Hospital Length of Stay (LOS) (time frame: 30 days post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02613728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.